TELLOMAK: T-cell Lymphoma anti-KIR3DL2 therapy
Research type
Research Study
Full title
TELLOMAK: T-cell Lymphoma anti-KIR3DL2 therapy - An open label, multi-cohort, multi-center phase II study evaluating the efficacy and safety of IPH4102 alone or in combination with chemotherapy in patients with advanced T-cell lymphoma
IRAS ID
261589
Contact name
Julia Scarisbrick
Contact email
Sponsor organisation
Innate Pharma SA
Eudract number
2018-003969-33
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
This research study is an open label, multi-cohort, multi-centre phase II study evaluating the effectiveness of the study drug, IPH4102, alone or in combination with chemotherapy in patients with advanced T-cell lymphoma (TCL).
Sezary Syndrome (SS), Mycosis Fungoides (MF) and peripheral T-cell lymphoma (PTCL) are all subtypes of TCL cancer. PTCL is the most common subtype of the disorders and to date has not been treated with IPH4102 or its combination with chemotherapy. SS is regarded as the blood subtype of CTCL. It is characterised by the combination of extensive skin lesions, high blood involvement with cancer cells and abormal enlargement of the lymph nodes. In SS, KIR3DL2, a protein expressed on the tumoral cell surface and the target of IPH4102, is widely expressed (more than 85% of patients). The expression is rather heterogeneous in MF and PTCL with around 50% of patients estimated to be KIR3DL2 expressing.
Current treatment options for relapsing TCL are limited highlighting the unmet medical need to find more effective treatment strategies.
Depending on the participant’s disease, they will be assigned to 1 of 3 cohorts. Patients will be treated with IPH4102 in all 3 cohorts.
IPH4102 is a monoclonal antibody designed to deplete KIR3DL2-expressing cells. KIR3DL2 is expressed across a variety of sub-types of TCL. This study aims to confirm the clinical activity of single agent IPH4102 in SS and characterise its efficacy and safety in MF.
The study will be conducted in around 30-40 sites in the USA and Europe, recruiting men and woman 18 years or over. 24 participants are planned to be enrolled in the United Kingdom.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
19/EE/0164
Date of REC Opinion
19 Jul 2019
REC opinion
Further Information Favourable Opinion